Endodontic DiseaseEarly Phase 1NCT05956613
Post Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis
A Early Phase 1 study testing Partial pulpotomy in people with Endodontic Disease, run by October 6 University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease
- What is being tested?
- Partial pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 22 Oct 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
- Inclusion criteria :
- Subject's age between 9-14 years.
- Both male and female subjects.
- Medically free and healthy subjects.
- Mandibular molar teeth.
- Teeth with symptomatic irreversible pulpitis.
- Teeth with mature closed apices.
- Exclusion Criteria:
- Teeth with acute dentoalveolar abscess.
- Subjects having more than one tooth that require root canal treatment.
- Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
- Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
- Teeth with periodontal disease or pulp calcification.
- Subjects taking chronic pain medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Pain After Partial Pulpotomy Versus Full Root Canal Treatment in Managing Young Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). The main question[s] it aims to answer are:
- In patients with symptomatic irreversible pulpitis does the use of bioceramic material in partial pulpotomy decrease amount of post operative pain in comparison to conventional root canal treatment?
Participants will record the intensity of pain at 24,48, 72 hours postoperatively.
- Conditions
- Endodontic Disease
- Being tested
- Partial pulpotomy
- Keywords
- bioceramic material, pulpitis, partial pulpotomy
- Medical subject headings
- Dental Pulp Diseases, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial pulpotomyProcedure or surgery
Use of newly introduced bioceramic putty in partial pulpotomy
| Study group | Role | What they receive |
|---|---|---|
| Control: conventional root canal treatment | No intervention | Not described |
| Test: partial pulpotomy | Other | Partial pulpotomy using bioceramic putty Receives: Procedure: Partial pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Measure intensity of post operative pain using visual analogue scale (VAS)
Measured: after 24 hours
Post operative pain
Measure intensity of post operative pain using visual analogue scale (VAS)
Measured: after 48 hours
Post operative pain
Measure intensity of post operative pain using visual analogue scale (VAS)
Measured: After 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Oct 2023
- Study completion22 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Omaia Ahmed Salah, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956613
- Sponsor's protocol ID
- RECO6U/27-2023
- Status last verified
- May 2024
- First submitted
- 7 Jul 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain After Partial Pulpotomy Versus Full Root Canal Treatment in Managing Young Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05956613
- Acronym / sponsor ID
- RECO6U/27-2023
- Conditions
- Endodontic Disease
- Keywords
- bioceramic material, pulpitis, partial pulpotomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 22 Oct 2023 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). The main question[s] it aims to answer are:
- In patients with symptomatic irreversible pulpitis does the use of bioceramic material in partial pulpotomy decrease amount of post operative pain in comparison to conventional root canal treatment?
Participants will record the intensity of pain at 24,48, 72 hours postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: conventional root canal treatment | No intervention | – |
| Test: partial pulpotomy | Other | Procedure: Partial pulpotomyPartial pulpotomy using bioceramic putty |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial pulpotomyUse of newly introduced bioceramic putty in partial pulpotomy | Procedure or surgery | Test: partial pulpotomy |
Primary outcome
Post operative pain
Time frame: after 24 hours
Measure intensity of post operative pain using visual analogue scale (VAS)
Post operative pain
Time frame: after 48 hours
Measure intensity of post operative pain using visual analogue scale (VAS)
Post operative pain
Time frame: After 72 hours
Measure intensity of post operative pain using visual analogue scale (VAS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Pulpitis
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Partial pulpotomy in people with Endodontic Disease, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: after 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.